68Ga-NOTA-3P-TATE-RGD for Dual Somatostatin Receptor and Integrin αvβ3 PET/CT Imaging of Lung Cancer and Neuroendocrine Neoplams
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Standardized uptake value of 68Ga-NOTA-3PTATE-RGD in lung cancer and Neuroendocrine Neoplasm
研究概览
简要总结
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluate the efficacy of 68Ga-NOTA-3PTATE-RGD in lung cancer patients and neuroendocrine neoplam patients. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-3P-TATE-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
详细描述
The number of somatostatin receptors may be greatly up-regulated in the cells of a variety of tumor including carcinoids, gastrinomas, paragangliomas, small cell lung cancer and non-small cell lung cancer. Octreotide is an eight amino acid cyclic peptide that preserves a four amino acid motif (Phe-Trp-Lys-Thr) that is critical for the biological activity of somatostatin (SSTR). On the other hand, the RGD moiety binds with integrin αvβ3, also plays an important role in the regulation of tumor growth, angiogenesis, local invasiveness, and metastatic potential in human tumor. To target both receptors, a heterodimeric peptide TATE-RGD was synthesized from TATE and RGD through a glutamate linker and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-3PTATE-RGD and diagnostic performance of 68Ga-NOTA-3PTATE-RGD PET/CT in evaluation of lung cancer and neuroendocrine neoplams.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neoplasm identified by X-ray, ultrasound or MRI as lung cancer or neuroendocrine tumors
- •To provide basic information and sign the written informed consent.
排除标准
- •Consisted of conditions of mental illness;
- •Severe liver or kidney disease with serum creatinine > 3.0 mg/dl (270 μΜ) or any hepatic enzyme level 5 times or more than normal upper limit;
- •Severe allergy or hypersensitivity to IV radiographic contrast
- •Claustrophobia to accept the PET/CT scanning
- •Pregnancy or breast feeding
研究组 & 干预措施
68Ga-NOTA-3P-TATE-RGD PET/CT
The patients were injected with 111-185 MBq of 68Ga-NOTA-3P-TATE-RGD in one dose intravenously and underwent PET/CT scan 45-60 min later.
干预措施: 68Ga-NOTA-3P-TATE-RGD (Drug)
结局指标
主要结局
Standardized uptake value of 68Ga-NOTA-3PTATE-RGD in lung cancer and Neuroendocrine Neoplasm
时间窗: 1 year
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast cancer will be measured.
次要结局
未报告次要终点